July 22, 2016
European CHMP Adopts Positive Opinion on Gilead’s Type II Variation Application for Truvada® for Reducing the Risk of Sexually Acquired HIV
– If Approved, Truvada for PrEP in Combination with Safer Sex
Practices Could Offer Uninfected Adults at High Risk a New Option to
Reduce the Risk of Acquiring HIV –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 22, 2016--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency (EMA), has adopted a positive opinion on
the company’s Type II variation application for once-daily Truvada® (emtricitabine
200 mg/tenofovir disoproxil 245 mg) in combination with safer sex
practices to reduce the risk of sexually acquired HIV-1 infection among
uninfected adults at high risk, a strategy known as pre-exposure
prophylaxis, or PrEP. Truvada was approved by the EMA in 2005 for use in
combination with other antiretroviral agents for the treatment of HIV-1
infection in adults, and is currently the most prescribed antiretroviral
medicine in Europe as part of combination therapy.
The CHMP’s recommendation will now be reviewed by the European
Commission, which has the authority to approve medicines for use in the
28 countries of the European Union (EU).
The Type II variation application is based on the results of two large
placebo-controlled trials of Truvada for PrEP, the Pre-Exposure
Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S.
National Institutes of Health and the University of Washington,
respectively. In studies of Truvada for PrEP, the most commonly reported
side effects included headache, stomach discomfort and weight loss.The
incidence and types of side effects were consistent with Truvada’s
safety and tolerability profile when used as part of an HIV treatment
“The CHMP’s opinion moves the medical community closer to being able to
offer an additional HIV prevention tool to people at high risk of HIV
acquisition across the entire EU,” said Professor Jean-Michel Molina,
MD, PhD, Hôpital Saint Louis in Paris and University of Paris 7.
“Evidence supports pre-exposure prophylaxis, in combination with safer
sex practices, to reduce the risk of sexually acquired HIV and we look
forward to the potential public health impact of PrEP, in addition to
increasing access to testing and universal treatment of people living
with the disease, in helping to lower HIV transmission rates in Europe.”
Worldwide, clinical guidelines support the use of PrEP, in combination
with existing prevention measures such as condoms, to prevent the sexual
transmission of HIV in adults at high risk of HIV infection. Truvada for
PrEP should not be used in individuals with unknown or positive HIV-1
status, as Truvada alone does not constitute a complete regimen for the
treatment of HIV-1 and HIV-1 resistance mutations have emerged in
individuals with undetected HIV-1 infection who are only taking Truvada.
Truvada is approved for PrEP in Australia, Canada, Kenya, Peru, South
Africa and the United States. Regulatory submissions are pending in
Brazil, Taiwan and Thailand. Additionally, within the EU, Truvada is
currently available for PrEP in France under a Temporary Recommendation
for Use by the French regulatory agency (ANSM).
The use of Truvada for PrEP is investigational in the EU and its safety
and efficacy have not been established.
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
Truvada for PrEP will not be approved by the European Commission or
other regulatory authorities, and any marketing approvals, if granted,
may have significant limitations on their use. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Quarterly
Report on Form 10-Q for the quarter ended March 31, 2016, as filed with
the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and
Gilead assumes no obligation to update any such forward-looking
The European SmPC for Truvada is available from the EMA website at www.ema.europa.eu.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
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Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Head, +44 (0)7768 705945